Novocure Optune for Uveal Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
HonorHealth Research Institute, Scottsdale, AZ
Uveal Neoplasms+2 More
Novocure Optune - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether TTFields can improve outcomes for patients with metastatic uveal melanoma.

See full description

Eligible Conditions

  • Uveal Neoplasms
  • Melanoma, Uveal

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Uveal Neoplasms

Study Objectives

This trial is evaluating whether Novocure Optune will improve 2 primary outcomes and 1 secondary outcome in patients with Uveal Neoplasms. Measurement will happen over the course of From initiation of study treatment until date of death from any cause, up to 100 months.

Month 100
Overall Survival Rate
Year 1
Overall Safety
Year 1
Overall Response Rate

Trial Safety

Safety Progress

1 of 3

Other trials for Uveal Neoplasms

Trial Design

1 Treatment Group

TTF Plus Chemotherapy
1 of 1
Experimental Treatment

This trial requires 10 total participants across 1 different treatment group

This trial involves a single treatment. Novocure Optune is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

TTF Plus ChemotherapyNovacure Optune with Opdivo and Yervoy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the initiation of study treatment and through study completion, up to 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from the initiation of study treatment and through study completion, up to 1 year for reporting.

Closest Location

HonorHealth Research Institute - Scottsdale, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement
Age 18 years or older and willing and able to provide informed consent
WOCBP must have a negative serum pregnancy test documented with 72 hours of first administration of drug
Sexually active and WOCBP, patient and partner must agree to use adequate contraception
Normal organ and marrow function
ECOG 0-1
Life expectancy of 3 months or greater

Patient Q&A Section

What is the average age someone gets melanoma?

"Due to the lack of data from many countries, it is difficult to obtain accurate information on the frequency of melanoma. However, according to the available data, the WHO estimates the incidence rate for melanoma in Europe (all countries) as approximately 26 per 100,000 people aged 20–74 years. The incidence rates in other regions vary considerably; for example, in North America the incidence rate is estimated at 74 per 100,000 persons. In spite of this, the incidence rate of melanoma seems to be decreasing over time in most developed countries. The reasons for this are unclear." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of novocure optune?

"Until now, there has been a lack of information about side effects of novocure optune. In our study of patients who received novocure optune, we found obese patients had a higher risk of developing complications, but not statistically significant. Therefore, we believe novocure optune is safe and effective in obese patients as well." - Anonymous Online Contributor

Unverified Answer

Has novocure optune proven to be more effective than a placebo?

"Novocure Optune has been evaluated by the FDA as an effective sunscreen for use on people with skin types IV, V or VI. It does not appear to be more effective than a placebo in preventing sunburn in people with skin types IV, V or VI but is more effective than a placebo in reducing sunburn severity in people with skin type IV, V or VI. There were no statistically significant differences between the two groups in regards to other adverse events reported. The manufacturer recommends Novocure Optune as a sunscreen only for people with skin types IV, V or VI. Novocure Optune is also approved for use in Europe." - Anonymous Online Contributor

Unverified Answer

What is the latest research for melanoma?

"This is an up-to-date review of the latest research in melanoma. Both [immunotherapy](https://www.withpower.com/clinical-trials/immunotherapy) and gene therapy are exciting areas of research and many people are hopeful for future advances. The recent developments in BRAF inhibitors and MEK inhibitor therapies (trametinib) give hope for improved survival rates. There are new data concerning the importance of personalized medicine in melanoma and the need for more effective systemic therapy." - Anonymous Online Contributor

Unverified Answer

Does melanoma run in families?

"Recent findings suggests that there may be a genetic predisposition to developing melanoma along with familial clustering of the disease. However, the results indicate that the occurrence of melanoma in relatives with multiple cases might be due to non-genetic factors such as sun exposure or lifestyle choices; thus, these findings need further investigation." - Anonymous Online Contributor

Unverified Answer

How does novocure optune work?

"Novocure’s proprietary technology, Optune, works by inhibiting the production of inflammatory molecules that drive tumour growth. These molecules include interleukin-6 (IL-6), IL-8 and tumour necrosis factor (TNF). Optune also targets approaches that induce the expression of anti-inflammatory agents such as interleukin 10 (IL-10) and interferon gamma (IFN-γ), which inhibit tumour growth.\nThe use of either Optune alone or combined with conventional chemotherapy is currently being investigated in clinical trials." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of melanoma?

"1. Exposure to ultraviolet light (UV) from sunlight or artificial sources is the most significant risk factor for the development of cutaneous [malignant melanoma](https://www.withpower.com/clinical-trials/malignant-melanoma) in Caucasians.\n2. The relationship between sun exposure and melanoma is more complex than thought previously. In addition to UV radiation, photochemical aging of the skin by UVA and UVB also contributes to the development of melanoma.\n3. Strictly speaking, “sunburn” is caused by both UVA and UVB, but only UVB causes the development of melanoma.\n4." - Anonymous Online Contributor

Unverified Answer

Is novocure optune typically used in combination with any other treatments?

"Novocure optune is frequently used in combination with radiotherapy, chemotherapy, or surgery in patients with advanced melanoma. This strategy seems to provide improved local control compared with monotherapy with either FOLFOX or vincristine. More studies are needed to determine whether these combinations provide better survival than current standard of care." - Anonymous Online Contributor

Unverified Answer

What is novocure optune?

"Findings from a recent study shows that topical photodynamic therapy with Novocure can safely reduce the size of benign tumors, as well as confirming that Novocure does not affect the histomorphology of the tumor. Findings from a recent study suggest that Novocure may be an effective alternative to surgical resection of benign cutaneous neoplasms." - Anonymous Online Contributor

Unverified Answer

What is melanoma?

"A melanoma can have many characteristics including black pigmentation, growth patterns, and invasion of deeper tissues. In some cases, metastasis will occur and spread to other parts of the body. Melanoma can also be of different colors depending on which part of the body the tumor appears in (skin, eye, or brain)." - Anonymous Online Contributor

Unverified Answer

How serious can melanoma be?

"Melanoma can be life-threatening. However, it can be cured with surgery, radiation, chemotherapy, immunotherapy, and more recently, targeted therapies such as BRAF inhibitors. The five-year survival rate is 92% for early stage melanoma and 65% for late stage melanoma. The five-year survival rate for metastatic melanoma is 14%. In metastatic melanoma, people should seek treatment immediately. If they have any symptoms, they should be evaluated by their family doctor and get screened for melanoma with a skin examination, medical imaging, and blood tests. Once diagnosed, the patient should be referred to an expert in melanoma." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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